Data / Medical devices / Mechanical Thrombolysis Catheter
Mechanical Thrombolysis Catheter (QEY): 13 FDA-registered makers in 3 countries
13 establishments in 3 countries are registered with the FDA to make Mechanical Thrombolysis Catheter (product code QEY, Class 2, 21 CFR 870.5150). 11 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 71 510(k) clearances under this code, the latest on February 17, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- QEY
- Device class
- 2
- Regulation
- 870.5150
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Costa Rica | 2 |
| Ireland | 2 |
Makers of Mechanical Thrombolysis Catheter
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 7 | April 20, 2022 | 0 | 2 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer | 7 | April 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | El Coyol Alajuela, Costa Rica | Manufacturer | 6 | April 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 5 | April 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 4 | September 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 4 | September 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 4 | October 31, 2016 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 3 | November 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Ireland, Ltd | Galway Galway(County), Ireland | Manufacturer | 3 | July 23, 1999 | 0 | 0 | 0 | api.fda.gov |
| Thrombolex, Inc. | New Britain, PA, United States | Specification developer | 3 | July 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Liquet Medical Inc. | Glen Allen, VA, United States | Specification developer | 1 | November 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Biomerics Alajuela | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiercel Surgical | New Britain, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.